Implanted Diaphragmatic/Phrenic Nerve Stimulator
Basic Information
- Device Name
- Implanted Diaphragmatic/Phrenic Nerve Stimulator
- Trade Name
- DIAPHAGMATIC/PHRENIC NERVE STIMULATOR
- PMA Number
- P860026
- Supplement Number
- S007
- Device Class
- FDA Class 3
- Product Code
- GZE
- Generic Name
- implanted diaphragmatic/phrenic nerve Stimulator
- Regulation Number
- 882.5830
- Medical Specialty
- Neurology
- Advisory Committee
- Anesthesiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 26, 2001
- Date Received
- November 16, 2000
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR CHANGING THE METHOD OF ATTACHING THE BATTERY CONNECTOR AND WIRING FROM THE POWER SWITCHES TO THE PRINTED CIRCUIT BOARD, CHANGING THE POINT WHERE THE SIGNAL IS TAKEN TO ILLUMINATE THE BATTERY LED INDICATOR, ADDING THE ENERGY SOURCE ROUTING TO THE FRONT PANEL OF THE RESPIRATORY RATE CONTROL CIRCUITRY, CHANGING THE POINT WHEE THE BATTERY POWER IS OBTAINED FOR EACH STIMULATOR OUTPUT AMPLIFIER CIRCUIT, AND DECREASING THE SENSITIVITY OF THE OSCILLATOR CIRCUIT TO TRANSISTOR OUTPUT CAPACITANCE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MARK IV AND IS INDICATED FOR PERSONS WHO REQUIRE CHRONIC VENTILATORY SUPPORT BECAUSE OF UPPER MOTOR NEURON RESPIRATORY MUSCLE PARALYSIS (RMP) OR BECAUSE OF CENTRAL ALVEOLAR HYPOVENTILATION (CAH) AND WHOSE REMAINING PHRENIC NERVE, LUNG, AND DIAPHRAGM FUNCTION IS SUFFICIENT TO ACCOMODATE ELECTRICAL STIMULATION.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GZE | Implanted Diaphragmatic/Phrenic Nerve Stimulator | FDA class 3 | Neurology |